FDA.reportPublic FDA data

IC-8 Apthera IOL

Primary DI
00813359021035
Brand
IC-8 Apthera IOL
Company
Bausch & Lomb Incorporated
Model
+25.0 D
Catalog number
82078-250
Device description
One-piece UV blocking, hydrophobic acrylic small aperture intraocular lens.
Published
2023-01-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
POEExtended Depth Of Focus Intraocular Lens

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
POEExtended Depth Of Focus Intraocular LensOphthalmic3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P210005000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P210005000IC-8 Apthera Intraocular Lens (IOL)Acu Focus, Inc.2022-07-22POE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00813359021035PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00813359021035008133590210358133590210350813359021035

GMDN Terms#

Term, Definition table
TermDefinition
Posterior-chamber intraocular lens, pseudophakic, extended-focusA sterile optical device intended to be implanted into the posterior chamber of the eye to replace the natural lens (crystalline lens), typically because it has been clouded by a cataract. It consists of an intraocular lens (IOL) containing a small aperture inlay device designed to provide extended depth of focus for near vision, achieved through the pinhole effect. The components are typically made of synthetic polymer; disposable devices associated with implantation (e.g., IOL injector) may be included with the lens.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
196603781
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10757770229908SoFlex® SE IOLLI61SELI61SE22002024-05-21
10757770096746PMMA (P359UV)P359UV2R0002015-09-17
10757770096760PMMA (P359UV)P359UV2R0102015-09-17
10757770096784PMMA (P359UV)P359UV2R0202015-09-17
10757770096807PMMA (P359UV)P359UV2R0302015-09-17
10757770096821PMMA (P359UV)P359UV2R0402015-09-17
10757770096845PMMA (P359UV)P359UV2R0502015-09-17
10757770096869PMMA (P359UV)P359UV2R0602015-09-17
10757770096883PMMA (P359UV)P359UV2R0702015-09-17
10757770096906PMMA (P359UV)P359UV2R0802015-09-17
10757770096920PMMA (P359UV)P359UV2R0902015-09-17
10757770096944PMMA (P359UV)P359UV2R1002015-09-17
10757770096951PMMA (P359UV)P359UV2R1052015-09-17
10757770096968PMMA (P359UV)P359UV2R1102015-09-17
10757770096975PMMA (P359UV)P359UV2R1152015-09-17
10757770096982PMMA (P359UV)P359UV2R1202015-09-17
10757770096999PMMA (P359UV)P359UV2R1252015-09-17
10757770097002PMMA (P359UV)P359UV2R1302015-09-17
10757770097019PMMA (P359UV)P359UV2R1352015-09-17
10757770097026PMMA (P359UV)P359UV2R1402015-09-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05050474806153PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806177PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806207PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806214PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806238PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806245PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806252PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806269PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806276PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806306PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806320PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806344PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806351PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806368PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806375PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806412PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806429PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806450PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806481PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806511PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806535PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806542PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806566PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806597PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806603PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806610PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806641PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806658PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474806689PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16
05050474818736PURESEE IOLJOHNSON & JOHNSON SURGICAL VISION, INC.POE2026-03-16